Atrial FibrillationPREDATE-AFNCT01851902
PREdicting Atrial Fibrillation or Flutter
An observational study of Atrial Fibrillation and Atrial Flutter, run by Keesler Air Force Base Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The PREDATE AF trial is a prospective, single arm, open-label, single center clinical study to evaluate the incidence of AF in patients that are suspected to be at high risk of having AF, as defined by a modified CHA2DS2-VASc score.
Who may be able to join
- Patient meets the approved FDA indication to receive the ICM
- Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator
- Patient has a CHA2DS2-VASc score ≥ 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.]
- Patient is 18 years of age or older
- Patient has a life expectancy of 18 months or more
Who cannot join
- Patient has a documented history of AF or atrial flutter
- Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use)
- Patient had an ischemic stroke or TIA within past year prior to enrollment
- Patient has a history of a hemorrhagic stroke
- Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator)
- NYHA Class IV Heart Failure patient
Show all 16Show fewer
- Patient had heart surgery within previous 90 days prior to enrollment
- Patient had an MI within the previous 90 days prior to enrollment
- Patient is taking chronic immunosuppressant therapy
- Patient is taking an anti-arrhythmic drug
- Patient is contraindicated for long term anticoagulation medication
- Patient is taking a long-term anticoagulation medication
- Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from the principal investigator
- Patient has a creatinine clearance <30 ml/min or is on dialysis
- Active pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Keesler Medical Center
Keesler Air Force Base, Mississippi, 39534
About this study
Official title: PREdicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF)"
The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.
Read the detailed description
Background: Atrial fibrillation and atrial flutter (AF) are common cardiac arrhythmias that confer a substantial stroke burden largely because the vast majority of AF is asymptomatic and identified after a stroke has occurred. Until recently, only intermittent cardiac monitors were available, with most AF episodes remaining undetected due to poor sensitivity. Health care providers estimate the risk of stroke in AF patients using a patient's comorbidity profile to determine who should be treated with oral anticoagulant therapy for stroke prevention. The incidence of AF in patients with high stroke risk comorbidities is not known. The Medtronic Reveal insertable cardiac monitor (ICM) is a continuous monitoring device with excellent AF detection.
Purpose and Study Objectives: The purpose of the PREDATE AF study is to determine the incidence of AF in asymptomatic patients at high risk for having AF in order to determine which patient characteristics are most predictive of the development of AF. The primary objective is to determine the AF incidence rate; secondary objectives include identifying the most important predictors of AF onset and identifying how physicians respond once AF has been discovered.
Study Design: The trial is a prospective, single arm, open-label, single center clinical study which will enroll up to 360 patients at high risk of having AF based upon their comorbidity profile, who will then receive an ICM. Enrolled subjects will be followed for a minimum of 18 months to monitor for the detection of AF. Monthly ICM data transmissions will be the mechanism of AF detection, and this information will be utilized to determine the AF incidence rate
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial Fibrillation, Atrial Flutter, Arrhythmia
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHA2DS2-VASc Score 2 - 4 | Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a low risk cohort. | |
| CHA2DS2-VASc Score 5 - 6 | Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a medium risk cohort. | |
| CHA2DS2-VASc Score 7 - 9 | Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a high risk cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial Fibrillation
Incidence rate of AF calculated in each arm as the number of participants with an initial episode of AF lasting greater than or equal to six minutes divided by the total number of participants in that arm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keesler Air Force Base Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Javed M Nasir, MD, Study director, Keesler Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851902
- Sponsor's protocol ID
- FKE20130012H
- Acronym
- PREDATE-AF
- Status last verified
- Jan 2016
- First submitted
- 2 May 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREdicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF)"
- ClinicalTrials.gov ID
- NCT01851902
- Acronym / sponsor ID
- PREDATE-AF / FKE20130012H
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial Fibrillation, Atrial Flutter, Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Keesler Air Force Base Medical CenterUS federal agency
- Study start
- May 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.
Detailed description
Background: Atrial fibrillation and atrial flutter (AF) are common cardiac arrhythmias that confer a substantial stroke burden largely because the vast majority of AF is asymptomatic and identified after a stroke has occurred. Until recently, only intermittent cardiac monitors were available, with most AF episodes remaining undetected due to poor sensitivity. Health care providers estimate the risk of stroke in AF patients using a patient's comorbidity profile to determine who should be treated with oral anticoagulant therapy for stroke prevention. The incidence of AF in patients with high stroke risk comorbidities is not known. The Medtronic Reveal insertable cardiac monitor (ICM) is a continuous monitoring device with excellent AF detection.
Purpose and Study Objectives: The purpose of the PREDATE AF study is to determine the incidence of AF in asymptomatic patients at high risk for having AF in order to determine which patient characteristics are most predictive of the development of AF. The primary objective is to determine the AF incidence rate; secondary objectives include identifying the most important predictors of AF onset and identifying how physicians respond once AF has been discovered.
Study Design: The trial is a prospective, single arm, open-label, single center clinical study which will enroll up to 360 patients at high risk of having AF based upon their comorbidity profile, who will then receive an ICM. Enrolled subjects will be followed for a minimum of 18 months to monitor for the detection of AF. Monthly ICM data transmissions will be the mechanism of AF detection, and this information will be utilized to determine the AF incidence rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHA2DS2-VASc Score 2 - 4 | – | –Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a low risk cohort. |
| CHA2DS2-VASc Score 5 - 6 | – | –Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a medium risk cohort. |
| CHA2DS2-VASc Score 7 - 9 | – | –Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a high risk cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The PREDATE AF trial is a prospective, single arm, open-label, single center clinical study to evaluate the incidence of AF in patients that are suspected to be at high risk of having AF, as defined by a modified CHA2DS2-VASc score.
Key inclusion criteria (5 listed)
- Patient meets the approved FDA indication to receive the ICM
- Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator
- Patient has a CHA2DS2-VASc score ≥ 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.]
- Patient is 18 years of age or older
- Patient has a life expectancy of 18 months or more
Key exclusion criteria (16 listed)
- Patient has a documented history of AF or atrial flutter
- Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use)
- Patient had an ischemic stroke or TIA within past year prior to enrollment
- Patient has a history of a hemorrhagic stroke
- Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Atrial Fibrillation
Time frame: 2 years
Incidence rate of AF calculated in each arm as the number of participants with an initial episode of AF lasting greater than or equal to six minutes divided by the total number of participants in that arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed M Nasir, MD study director
Keesler Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Keesler Air Force Base Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Atrial Fibrillation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.